Means Engineering, Inc.

Product development engineering in medical, industrial, semiconductor equipment & military with a standard of excellence in form, function and design.

(760) 931-9452 | info@meanseng.com
5927 Geiger Court, Carlsbad, CA 92008-7305

Manufacturing During COVID-19 – Keeping Staff Safe

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The COVID-19 public health emergency has forced businesses around the globe to reconsider the ways they handle daily tasks and operations. For businesses in the manufacturing industry, leaders have had to implement important safety measures while preparing for increased uncertainty and long-lasting changes to the work environment.

Unlike a lot of other industries, manufacturing requires heavy equipment, machinery, adequate space, and often a controlled environment. This makes working from home extremely difficult.

In order to continue operations and ensure the organizations we support can continue to thrive in a struggling economy, Means Engineering has developed a COVID-19 response plan to ensure the safety and continued well-being of our employees.

At Mean Engineering, the health and safety of our staff has always been our top priority. We have been able to stay open during the public health emergency by implementing proper safety procedures. We also developed a COVID-19 task force. The main focus of this task force is to ensure the continuous safety and well-being of our employees.

In addition to implementing CDC recommended cleaning and sanitation practices, our COVID-19 task force monitors employee health, and implements additional safety measures as recommended by leading authorities.

Preventing the Spread of Disease Takes a Team Effort

At Means Engineering, our people don’t just help organizations create new products, they bring years of industry expertise and insight to the table. They offer viable solutions to a wide range of design and production development issues. Our people truly are what sets Means Engineering apart.

Our COVID-19 plan and task force were developed following Means Engineering’s core values. These values play an important role in every decision we make.

  • Passion –  At the center of everything we do
  • Integrity– We hold ourselves to high standards and honor the commitments we make. We strive to embody integrity in all our processes, decisions, and interactions
  • Innovation– Innovation is in our DNA as a company. We are constantly developing and supporting new methods and ideas to build products
  • Quality– We are dedicated to quality and always strive to produce products that meet or exceed quality standards.
  • Ethics– We believe in doing what’s right for the customer, right for our employees, and right for the world

Every month, Means Engineering hosts company-sponsored events. These events allow us to unwind and connect as a team. We believe this is where innovation begins. Unfortunately, during the COVID-19 pandemic, we’ve had to put these events on hold. However, we continue to show our appreciation to our staff through food trucks, cookies, and by providing them with plenty of Means Engineering merchandise.

Although life looks a little different now, we plan to continue to grow and adjust as a team. We believe this will strengthen our ability to exceed our customers’ expectations for both quality and service.

Please contact us for more information about our contract manufacturing services and the steps we’re taking to keep our staff safe.

 

 

How the Internet of Things is Changing Healthcare

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Outcomes-based healthcare is quickly becoming the new norm. In fact, organizations that do not embrace outcomes-based health plans will soon fall behind their competition. A recent study conducted by Avalere Health, a leading healthcare consulting plan, found that outcomes-based contract discussions are up 25% among leading health plans.

For healthcare providers, making the switch from a traditional capital expenditure model to a usage-based system makes sense. This model allows providers to charge more competitively for services. However, for medical device manufacturers, this model represents a major shift from the way things have always been done. As more providers adopt an outcomes-based system, medical device manufacturers can no longer base their designs, development, and marketing on big-ticket equipment sales.

Another change, providers now expect medical devices to include embedded software and connectivity. An important feature, this enables patient health data collection and transmission to providers and healthcare networks. This is extremely important to the outcomes-driven model. Connected devices enable providers to view patient data in real-time, increasing diagnostic capabilities and improving outcomes for patients. The medical devices of today need to include numerous features and capabilities.

IoT Medical Devices Allow for Faster Diagnosis and Better Outcomes

The Internet of Things (IoT) allows providers to remotely monitor patients. This reduces downtime and increases the predictive maintenance efficiency of medical devices. By adding a variety of sensors, manufacturers allow medical devices to capture a wide range of data. This could provide a much more complete picture of patient health. Through machine learning and AI, devices and/or providers can react in real-time to changes to a patient’s condition or health.

Making Medical Devices Smart

While most medical device manufacturers understand the importance of making medical devices “smart”, many don’t have the tools, technology, or people to produce medical devices for rapidly evolving needs. Unfortunately, medical device manufacturers that cannot keep up with advancing technology will soon find it difficult to attract new customers or maintain existing accounts. The shift to IoT is evolving quickly and recent predictions show that healthcare related IoT will top $135 billion by 2025.

Organizations unsure of how to embed software and connectivity into medical devices could benefit from outsourcing to a competent and experienced medical device contract manufacturer. Means Engineering has years of experience and understands the complex and changing needs of the medical device industry.  We have ISO 13485 certification and our team is dedicated to exceeding customer expectations for both quality and service.

When you work with Means Engineering, we work directly with your organization to ensure you fully understand every step of the process. Our services are scalable, ensuring a right-sized approach for each project. Following our core values: passion, integrity, innovation, and ethics, our team works together to complete projects on-time and on-budget.

Please contact us for more information about our services.

 

 

The Importance of ISO 13485 Certification

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Organizations responsible for the design and production of medical devices need to understand the strict standards and requirements of government officials. Used for a wide range of applications, medical devices may mean the difference between life and death for those that rely on them. In the United States, medical devices are regulated by the FDA and organizations must receive ISO 13485 certification prior to their design or assembly.

About ISO 13485

ISO 13485:2016 aligns with ISO 9001:2008. It’s important to note that this version of ISO 9001 does not include the same Annex L of the 2015 version. ISO 13485 includes several safety requirements to ensure the quality and reliability of devices created for the medical industry.

Although several countries have their own set of regulations regarding medical device design and creation, ISO 13485 is the main Quality Management System (QMS) standard for medical devices. While organizations in the United States must meet both ISO 13485 and FDA requirements, the FDA plans to eventually harmonize the two.

Despite what many people believe, ISO 13485 is aimed at ensuring high quality products. It is not a standard for products. Instead, ISO 13485 is a process based standard. When followed, these processes ensure a quality end product.

Organizations or businesses receive ISO certification. Individual people cannot become certified in ISO 13485. However, one person in an organization can receive certification as an ISO 13485 Certified Lead Auditor.

Becoming ISO 13485 Certified

Organizations wishing to become ISO 13485 certified must meet strict requirements. This is necessary to ensure the organization fully understands the processes required to create high quality medical devices. Organizations must take all necessary steps to implement an ISO 13485 quality management system. They must then undergo an audit by a Certification Body (CB). If the organization passes the audit, they receive ISO 13485 certification for three years. They must get re-certified after the initial three-year period.

ISO Certified Medical Device Manufacturer

Means Engineering has the people, equipment, and technology needed to produce high quality medical devices. In addition to ensuring the proper practices and standards within our organization, we have taken the steps necessary to become ISO 13485 certified. This puts us in the best possible position to help with the design and production of a wide range of products.

When you work with Means Engineering, you gain access to the knowledge and experience of our highly qualified team. We work directly with our clients to ensure adequate communication throughout the entire process. Please contact us to learn more about our contract manufacturing services for the medical industry.

 

The Importance of Clean Rooms in Medical Device Creation

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When producing medical devices, medical device manufacturers must maintain a clean environment. This is important, as any bacteria or microorganisms can create a safety concern for patients. It’s also crucial that medical device manufacturers ensure that air pollutants don’t gather on small components, impacting their ability to function as desired. In order to keep medical devices free from contaminants, medical device manufacturers must assemble these products in a controlled environment. Using a cleanroom for medical device assembly ensures bacteria and pollutants do not impact the functionality or safety of medical devices.

Ensuring Compliance with Federal Regulations Regarding Medical Device Creation

Companies responsible for the creation of devices for the medical industry must meet strict regulations regarding the design, production, and labeling of medical devices. Regardless of the type of device and its classification with the FDA, medical device manufacturers must ensure adequate cleanliness throughout the entire manufacturing process.

The International Organization for Standardization (ISO) sets the standard for quality for the medical device industry. Companies that receive ISO 13485 certification have proven they have the tools and capabilities to ensure optimal cleanliness and contamination controls when producing medical devices.

What is a Cleanroom?

A cleanroom is a special room, typically inside a manufacturing facility with special filtration used to remove contaminants like dust, airborne microbes, and aerosol particles. Manufacturers often use cleanrooms to produce electronics, pharmaceuticals, and medical devices. In addition to cleanliness and contamination control, cleanrooms also control temperature, air flow, and humidity all of which can impact the quality of finished products.

Do You Need a Cleanroom?

Organizations often wonder whether they need their own cleanroom. For organizations creating medical devices, a cleanroom is important to ensure the quality and safety of finished products. However, finding the space and funding for a cleanroom could create a challenge. Many small and mid-size companies often struggle to justify the cost of implementing cleanroom operations into their facility. It takes a lot of people and training to ensure the safe and proper production of these important devices.

Companies can benefit from outsourcing medical device production to an ISO 13485 certified contract manufacturer like Means Engineering. Our team has years of experience and understands how to design and produce a wide range of medical devices. We offer state of the art cleanroom assembly to ensure optimal cleanliness and quality.

Right Sized Contract Manufacturing Services

When you work with Means Engineering, we work directly with you to develop a customized solution. Unlike larger contract manufacturing firms, we offer a personalized approach. No matter how big or small your project, our team stays in communication throughout the entire process.

Please contact us for more information about our medical device contract manufacturing services.

 

 

Creating High Quality Medical Devices

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Medical devices help ensure quality of life for people around the globe. Used for a variety of diagnostic and treatment purposes, these devices play an important role in safeguarding the well-being of our increasingly health conscious population. Thanks to medical devices, diseases get caught earlier, improving outcomes and decreasing the cost of healthcare for millions of Americans.

Medical Devices Must Meet Strict Regulatory Requirements

When it comes to medical device creation, it’s crucial that organizations follow strict guidelines to ensure the production of high quality and reliable products. Regardless of intended use, medical devices face some of the toughest regulatory guidelines of any industry. It is up to developers and innovators to understand these regulations and ensure compliance when designing and producing devices for the medical industry.

In the United States, medical devices are regulated by the Food and Drug Administration (FDA) and the Centers for Devices and Radiological Health (CDRH). Based on associated risk, medical devices receive a Class I, Class II, or Class III classification. While Class I devices carry the lowest associated risk, Class III devices have the highest. The level of regulatory control depends on device classification.

Outsourcing Medical Device Design & Production

Companies looking to enter the medical device industry often find it difficult and confusing to understand the different CFR’s associated with the design, development, labeling, and production of medical devices. This is enough to keep many organizations out of the medical device industry altogether. However, this probably isn’t the best choice. The medical device and diagnostic industry is worth over $300 billion.

Organizations looking to produce high quality medical devices could benefit significantly from partnering with a trusted medical contract manufacturing service provider. Outsourcing to an ISO 13485 certified contract manufacturer ensures the production of high quality devices that meet strict regulatory compliance requirements. But this is just one piece of the puzzle. Organizations must also look for a partner that’s easy to work with and understands the importance of treating their staff and partners with the respect and attention they deserve.

Southern California Medical Device Contract Manufacturer

Means Engineering works directly with each of our valued customers to help develop a solution that exceeds their expectations in regards to both quality and care. Our vertically integrated approach makes it possible for partners to maintain control and monitor every step of the manufacturing process. By handling everything in-house, Means Engineering provides increased visibility and simplified supply chain coordination.

If you’re considering venturing into the medical device industry, or you require assistance with your existing medical device design and/or production, we encourage you to contact us to see why we’re the Southern California contract manufacturer of choice. We look forward to hearing from you.

 

ABOUT US

MEI features depth of experience in medical, industrial, semiconductor equipment and military products. All product development efforts start with a unique set of requirements, yet we deliver results that share a common standard of excellence in form, function and design.

Our turn-key capabilities provide smart, simple solutions to cumbersome outsourcing issues, and provide our clients with an intelligent route from concept to market.

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